Quality Associate Derby, England
Job description
Quality Associate
Due to continued expansion, we are currently seeking a Quality Associate to join our team in a well-established consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key part of a growing company in the pharmaceutical space.
We hold our own MIA and Man A, both in the UK and Ireland, to enable the importation of medicines into both the EEA and the UK. Alongside this, we also develop, implement and assist in the operation of WDAs for our clients, who are typically the Marketing Authorisation holders (MAH).
The role will be to support the Quality team and QPs in the generation and revision of Quality documentation, as well as the review and compilation of batch-related documentation, generated both internally and externally.
Key Duties and Responsibilities
- Review of the batch manufacturing/testing/packaging documentation for compliance with approved procedures and the product licence, for submission to the Qualified Person for release.
- Liaising with contract laboratories to ensure the timely analysis of products in preparation for QP certification.
- Management of the archiving of Quality documentation to ensure compliance with company policies and procedures as well as regulatory guidelines.
- Liaising with suppliers regarding quality or batch related issues, assisting with investigations, where necessary, and supporting the resolution of issues.
- Ensuring that all changes are entered into appropriate quality systems to ensure the change is consistently implemented to the required standards, with all relevant and supporting activities undertaken.
- Writing and review of Deviation Reports and CAPAs.
- Review of master processing documents against licence details and Technical Agreements prior to use.
- Participation in the internal audit programme.
- Participation in external audits of suppliers (as appropriate) and providing support for any assessment activities.
- Participation in regulatory audits (as appropriate) and providing support for assessment activities.
- Providing support in maintaining the Documentation System to ensure that all relevant procedures are documented and are in compliance with company policy and regulatory requirements.
- Requesting, executing and reviewing Product Quality Review reports.
- The writing and amendment of Standard Operating Procedures that cover GxP activities.
- Recording and meeting Quality department Key Performance Indicators (KPIs).
- Providing support in project based activities.
- Providing training as requested, and in line with current internal policies regarding training, to support ongoing GxP requirements and understanding.
Role Requirements
- Educated to degree Level standard, or equivalent. A degree in Chemistry, Pharmacy, Biochemistry, Microbiology or Biology would be desirable.
- Effective time management skills with a flexible approach and the ability to adapt quickly to changing priorities.
- Self-motivated and organised with ability to work using own initiative and as a team.
- Good attention to detail and ability to follow defined procedures and regulatory guidelines.
- Excellent interpersonal and communication skills.
- Good IT skills (Excel, PowerPoint, Outlook, Word).
Package Details
Competitive salary commensurate with experience, Annual performance related bonus, Contributory Pension, 25 days annual leave, East Midlands Office based.
The role is a full-time permanent position.
About Us
Callisto Pharma Group has grown from the formation, in 2003, of Callisto Regulatory Consulting Ltd, which provided regulatory and technical support to pharmaceutical manufacturers to a group comprising of three companies that can provide a complete range of technical services across the whole supply chain to multiple regulated sectors including human, veterinary and herbal medicines, borderline products, biocides, medical devices and food supplements.
We work across the UK, Europe, and the rest of the world for Clients operating in highly regulated sectors, ranging from global multi-nationals to single product licence holders.
We are committed to investing in our people and infrastructure which enable us to be highly flexible, efficient and innovative in our services to Clients
Job Types: Full-time, Permanent
Schedule:
- Monday to Friday
Experience:
- GMP Quality assurance: 3 years (required)
Work authorisation:
- United Kingdom (required)
Work Location: Hybrid remote in Derby DE74
Reference ID: QA-01-23
